Supplier Quality Engineer Lead

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: Trumbull CT or Livingston NJ (on-site)

Scope:

The Supplier Quality Engineer Lead is responsible for strategic leadership and execution of the Global Supplier Quality Management Program. This role provides functional leadership across supplier quality activities ensures regulatory and QMS compliance and drives continuous improvement across critical and strategic suppliers. The Lead operates with a high degree of autonomy influences crossfunctional and senior leadership decisions and sets direction for supplier quality governance risk management and performance improvement.

Job Summary:

The Supplier Quality Engineer Lead governs supplier qualification compliance auditing development and escalation activities for highrisk highimpact and strategic suppliers. This role owns supplier quality strategy serves as escalation point for complex supplier issues and regulatory interactions and plays a key role in management review audit readiness and organizational quality maturity. The position provides leadership and mentoring to Supplier Quality Engineers and partners closely with Procurement Operations Engineering Regulatory and Business Leaders.

Supplier Quality Leadership & Strategy

• Define and lead supplier quality strategy aligned with business objectives and regulatory requirements.
• Provide functional leadership and mentoring to Supplier Quality Engineers.
• Serve as escalation point for supplier quality issues Risk 1 suppliers outsourced processes and supply chain disruptions.
• Influence senior leadership decisions related to supplier risk sourcing strategy and business continuity.

Supplier Audits & Regulatory Compliance

• Lead planning and execution of global supplier audit programs (onsite remote desktop).
• Ensure effective management escalation and closure of audit findings and compliance gaps.
• Act as primary Quality representative for supplier-related regulatory inspections notified body audits and health authority inquiries.

Supplier Performance & Risk Governance

• Establish and oversee supplier risk classification risk assessment and mitigation frameworks.
• Review trend and present supplier performance metrics and risk data to Management Review and senior leadership.
• Ensure proactive identification of systemic supplier risks and continuous monitoring of supplier health.

Corrective Action Escalation & Change Management

• Provide oversight and escalation leadership for Supplier Corrective Action Requests (SCARs) ensuring robust root cause and sustained effectiveness.
• Lead supplier-related Nonconforming Material Reports (NCMRs) and support critical escalations.
• Evaluate and manage Supplier Change Notifications (SCNs) and change impact assessments.

Supplier Development & Continuous Improvement

• Lead supplier development initiatives focused on quality improvement compliance delivery performance and resiliency.
• Support New Product Introduction (NPI) supplier transfers localization and dualsourcing initiatives.
• Provide quality leadership for supplier-facing validation activities (IQ/OQ/PQ PPAP qualifications).

Quality Systems & Governance

• Develop Maintain governance and continuous improvement of Supplier Quality Agreements SOPs workflows and metrics.
• Ensure supplier documentation records and controls remain compliant with QMS and regulatory expectations.
• Drive crossfunctional alignment across the supplier lifecycle from selection through postmarket support.

Travel:This position may require 15-30% domestic and/or international travel.

Knowledge Skills and Abilities:

• Expert knowledge of FDA QSR (21 CFR 820) ISO 13485 EU MDR ISO 14971.

• Strong leadership experience in supplier quality governance audits CAPA/SCAR and risk management.

• Demonstrated ability to lead through influence and manage complex crossfunctional initiatives.

• Advanced problemsolving and quality tool expertise (RCA FMEA statistical analysis).

• Executivelevel communication skills with internal leadership and external suppliers.

• Proficiency with MS Office Minitab ERP systems and eQMS platforms.

Experience:

• 7 years experience in Supplier/Vendor Quality Management.

• 10 years experience in a regulated quality environment (medical device pharma life sciences).

• Proven leadership of highrisk suppliers regulatory interactions and global supplier initiatives.

Work Environment:

• Manufacturing clean room warehouse and office environments.

• May require extended periods of sitting standing and movement in production and supplier facilities.

Education:

• Bachelors Degree in Chemical Electro-Mechanical Industrial Biomedical Bioprocess Engineering or related to Life Science field or equivalent experience or skillset.

• CQE ASQ APICS Six Sigma Green Belt/Black Belt preferred.

#LI-KA1

Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$120000.00 - $150000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.